Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K173041 |
Device Name |
3DIEMME RealGUIDE |
Applicant |
3DIEMME Ltd. |
Via Risorgimento 9 |
Cantu,
IT
22063
|
|
Applicant Contact |
Alessandro Montroni |
Correspondent |
Registar Corp |
144 Research Drive |
Hampton,
VA
23666
|
|
Correspondent Contact |
Lara Luzak |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/28/2017 |
Decision Date | 12/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|